At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 90 enrolled
Drug / intervention
Ipilimumab IT +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase I/II Trial Evaluating the Safety & Efficacy of Intra-Tumoral Ipilimumab in Combination With Intra-venous Nivolumab in Patients With Metastatic Melanoma
In Brief
A Phase 2 clinical trial evaluating Ipilimumab IT, Ipilimumab IV, and 1 other intervention for Stage III/IV Melanoma. Completed, enrolled 90 participants across 1 site.
Detailed Summary
The study aims to evaluate the 6 month-treatment tolerance defined as the immune related grade 3-4 adverse event-free survival of the combination therapy IT ipilimumab + IV nivolumab. The IV ipilimumab + IV nivolumab (same doses than in Phase I) arm will be used as an internal control to interpret the results obtained in the IT ipilimumab arm.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage III/IV Melanoma
CountriesFrance
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartDec 2016
Primary CompletionJan 2021
Study CompletionMay 2022
TodayJul 2026
First PostedAug 5, 2016
Enrollment StartDec 5, 2016
Primary CompletionJan 1, 2021
Study CompletionMay 20, 2022
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 9.9 years ago
Interventions
Ipilimumab ITdrug
Ipilimumab IVdrug
Nivolumab IVdrug